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| Name | Class |
|---|---|
| Imperial College London | OTHER |
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The purpose of this research project is to measure changes in communication, swallowing and quality of life and individual patient priorities which may happen over time in patients with a diagnosis of recurrent head and neck cancer, specifically recurrent cancer (cancer which has returned after previous treatment) of the back of the throat, the tonsils and/or the base of tongue (recurrent oropharyngeal cancer) and what it is like for patients and their significant others to experience these changes over time.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment for recurrent oropharyngeal cancer (curative/ palliative) | Other | Open salvage surgery, transoral robotic surgery, palliative chemotherapy, immunotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Swallowing Related Quality of Life | Performance Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet (NoD) scores Three subscales: Normalcy of Diet, Understandability of Speech, Eating in Public Scores are combined to describe patient function in 6 areas (physical well-being, social and family well-being, relationship with doctor, emotional well-being, functional well-being, head & neck related symptoms) Total score Scale 0 -100, a higher score indicating better performance/higher quality of life The score reported is the combined score with the total being the sum of the sub-scale scores | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing Status Measured Using the 100ml Water Swallow Test | The Water Swallow Test is used to monitor swallow performance and possible aspiration - patients are viewed to have failed the test if they cough, have a wet voice quality post swallow or are unable to complete the task. | Baseline, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a confirmed diagnosis of recurrent, residual or new primary oropharyneal cancer in a previously irradiated field.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
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Difficulties recruiting participants to the study, number recruited will be adequate for analysis and will meet criteria for primary endpoint
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Patients with a diagnosis of recurrent oropharyngeal cancer - prospective |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2024 |
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| Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS) |
The scale consists of 8 levels (0-7) where drinks are measured as 0-4 to describe thickness (0 being thin, 4 being extremely thick) and foods are measured as 3-7 (3 being liquidised, 7 being regular/easy to chew) A higher score indicates a higher level of swallowing function, 0 being the lowest score, 7 being the highest score |
| Baseline, 3 months, 6 months |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Patients with a diagnosis of recurrent oropharyngeal cancer - prospective |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | YEARS |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Reported Swallowing Related Quality of Life | Performance Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet (NoD) scores Three subscales: Normalcy of Diet, Understandability of Speech, Eating in Public Scores are combined to describe patient function in 6 areas (physical well-being, social and family well-being, relationship with doctor, emotional well-being, functional well-being, head & neck related symptoms) Total score Scale 0 -100, a higher score indicating better performance/higher quality of life The score reported is the combined score with the total being the sum of the sub-scale scores | Posted | Median | Full Range | score on a scale | Baseline, 3 months, 6 months |
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| Secondary | Swallowing Status Measured Using the 100ml Water Swallow Test | The Water Swallow Test is used to monitor swallow performance and possible aspiration - patients are viewed to have failed the test if they cough, have a wet voice quality post swallow or are unable to complete the task. | Some participants were unable to complete/did not wish to complete the water swallow test | Posted | Median | Inter-Quartile Range | ml/second | Baseline, 3 months, 6 months |
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| Secondary | Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS) | The scale consists of 8 levels (0-7) where drinks are measured as 0-4 to describe thickness (0 being thin, 4 being extremely thick) and foods are measured as 3-7 (3 being liquidised, 7 being regular/easy to chew) A higher score indicates a higher level of swallowing function, 0 being the lowest score, 7 being the highest score | Not all participants completed the questionnaire | Posted | Median | Full Range | score on a scale | Baseline, 3 months, 6 months |
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All-Cause Mortality was assessed up to 6 months
All-Cause Mortality was assessed up to 6 months - no other adverse event data collected due to non-interventional nature of study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Patients with a diagnosis of recurrent oropharyngeal cancer - prospective | 2 | 25 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Grainne Brady | The Royal Marsden NHS Foundation Trust | 0000000000000 | grainne.brady@rmh.nhs.uk |
| Mar 18, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Unknown or Not Reported |
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| Title | Measurements |
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